Senior Clinical Trial Manager – Oncology

This is a fully remote position, open to applicants in Poland.

📋 Description

• Provide leadership and guidance to the clinical site management team from the initiation to the conclusion of studies.

• Supervise regional Clinical Trial Managers (CTMs) and facilitate collaboration within the CTM team.

• Address Site Management concerns at Sponsor, Investigator, and bid defense meetings.

• Serve as the primary contact for study-related activities.

• Contribute to the comprehensive project plan and develop global monitoring strategies for designated regions.

• Assign sites on behalf of the sponsor.

• Take on a dual role as Project Manager (PM) and CTM when necessary.

• Create, maintain, and ensure adherence to Clinical Monitoring Plans, including budgets, study tools, and site visit reports.

• Evaluate protocol deviations, out-of-scope items, and action items.

• Train and oversee the Clinical Research Associate (CRA) team on clinical study aspects.

• Engage in the development and execution of recruitment strategies.

• Anticipate site visits with the CRA team to meet staffing requirements and manage backlogs.

• Mentor CTMs as needed.

• Conduct co-monitoring visits.

• Review and finalize trip reports in accordance with WCT Standard Operating Procedures (SOPs).

• Assist study teams during healthcare authority inspections or sponsor audits.

⛳️ Requirements

• Exceptional interpersonal, verbal, and written communication skills in English and the local language.

• Capability to lead and inspire a remote team.

• Strong initiative and problem-solving abilities.

• High level of customer focus and professional engagement with sponsors.

• Proficient in Microsoft Office, Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) systems.

• Bachelor’s degree or equivalent in biological, physical, or health studies with at least 4 years as a Senior Clinical Research Associate or equivalent experience.

• Alternatively, an associate degree or equivalent education/training with a minimum of 6 years as a Senior Clinical Research Associate.

• At least 2 years of relevant experience as a CTM/LCRA or equivalent, including supervision of a CTM team.

• Experience with Oncology studies is mandatory.

• Willingness to travel.

🏝️ Benefits

• Diverse and inclusive work environment.

• Supportive, team-oriented atmosphere.

• Hands-on, approachable leadership.

• Equal employment opportunities.

• Employee experiences where every individual is respected and has access to equal opportunities.